Breast implants are a manufactured prosthesis used in cosmetic and reconstructive surgery. A breast implant has an outer casing or membrane that is filled with a fluid such as saline or a gelatinous cohesive silicone. Currently only about thirty percent (30%) of breast implant procedures are performed with an insertion device. An insertion device improves both the sterility of the surgical procedure and the patient outcome. Without an insertion device, the surgeon makes the incision, creates a pocket for the implant, opens the incision with a retractor and then manually pushes the implant into the pocket.
Different than a silicone implant, a saline implant is inserted into the pocket in an empty configuration. Once placed in the pocket, the surgeon takes the additional step of filling the empty implant with a saline solution using a fill tube. The incision is made in one of four places: in the armpit, in the breast fold, in the navel, or around the areola. Except for the navel insertion, one incision is made for each implant. It is preferable that the incision be as short as possible. Shorter incisions are less unsightly. This goal of a shorter incision is easier to accomplish with a saline implant. A saline implant is relatively easy to insert through a short incision, as the implant is unfilled and therefore small as it passes through the incision. For these inflatable implants, the surgeon rolls up the implant like a cigar and pushes it through the incision and into the pocket. In contrast, silicone implants are prefilled by the manufacturer resulting in a more difficult and complication-susceptible operation. For these pre-filled implants, the procedure requires a longer incision length.
After the initial incisions, the surgeon dissects a path through the tissue to the desired destination of the implant. Once that path has been created, a pocket is created for the implant superficial or deep to the pectoralis major muscle. The pocket may be formed in one of two places under the breast: subglandular (between the breast tissue and pectoralis major muscle) or subpectoral (under the pectoralis major muscle). The subglandular position places the prosthesis directly behind the mammary gland and in front of the pectoralis major muscle. Subpectoral places the implant partially under the pectoralis major muscle. Due to the shape and position of the pectoralis major muscle, a portion of the implant is not covered by the muscle.
Secondary surgery is common for patients with breast implants. Patients with breast implants may require surgery to change the placement (from subglandular to subpectoral or vice versa), correct palpable folding of the implant, remove a ruptured implant, treat infection, bleeding, breast pain, contracted scar tissue forming around the implant and collections of fluid around the implant. These additional surgeries have risks due to anesthesia, infection and bleeding. The overall secondary operation complication rate is about 15-18% for silicone gel breast augmentation within 3 years of the initial operation and up to 36-42% by 10 years from the initial breast implant surgery. Many re-operations are related to implant rupture (leakage), bleeding or capsular contracture. The major cause of re-operation after breast augmentation surgery is capsular contracture caused by shrinkage or contracture of the sac or capsule the body naturally forms around the implant.
Cellulitis, a skin-based infection, occurs in 2%-4% of patients, with some surgeons reporting much higher rates, and is usually from the bacteria normally present on the skin. Symptoms of infection may include fever, pain, swelling and redness. To reduce infection, surgeons give a single dose of antibiotics before the surgery, and use an antibiotic solution in the wound before implant placement. The antibiotic solution may double as the lubrication to allow easier insertion of the implant into the pocket. However, surgeons can reduce the rate of capsular contracture and infection down further by preventing the implant from touching the patient's skin during the insertion of the breast implant.
The implant insertion devices heretofore known suffer from several disadvantages:                1. The surgeon uses a single insertion end of the device to insert both implants exposing the second incision to bacterial contamination from the insertion device end touching the skin of the initial (first) incision and delivering bacteria into the second incision resulting in cellulitis, infection and or capsular contraction;        2. Requires the surgeon to resize the insertion device mid-operation to match two different implant sizes;        3. The opening through which the implant is loaded into the device is large enough for the implant to inadvertently slip out of the device resulting in bacteria on the skin touching the implant; and        4. The high cost of current implant insertion devices encourages re-use despite the manufacturer recommendation not to do so.        